Recall Z-2335-2018— St Jude Medical Inc.

Name: FDA recall Z-2335-2018
Creator: U.S. Food and Drug Administration
Published: 2018-04-16

Class II · Terminated

Class II FDA medical device recall by St Jude Medical Inc., initiated 2018-04-16, terminated 2021-02-04. It names one FDA 510(k) clearance: K163407. Product: Merlin PCS Programmer Software: 3330 The Merlin PCS programmer (model 3650) is a portable, external device used to support the implanted device, and for this recall the software that resides on the programmer (software model 3330) is the method of delivery of the new firmware.. Reason: The firm is advising physicians that exposure to sub-freezing temperatures during the supply chain process caused a transient battery voltage drop for a small number of Confirm Rx Model DM3500 Insertable Cardiac Monitoring (ICM) devices. This drop is an expected and normal behavior for this battery chemistry, but causes an incorrect display of a low battery indicator even after the battery voltage returns to normal..

Recalling firm: St Jude Medical Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-04-16
Terminated: 2021-02-04
Firm location: Sylmar, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K163407 — Confirm Rx Insertable Cardiac Monitor (ICM) SystemSt. Jude Medical, Inc.·cleared 2017-09-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Merlin PCS Programmer Software: 3330 The Merlin PCS programmer (model 3650) is a portable, external device used to support the implanted device, and for this recall the software that resides on the programmer (software model 3330) is the method of delivery of the new firmware.

Reason for recall

The firm is advising physicians that exposure to sub-freezing temperatures during the supply chain process caused a transient battery voltage drop for a small number of Confirm Rx Model DM3500 Insertable Cardiac Monitoring (ICM) devices. This drop is an expected and normal behavior for this battery chemistry, but causes an incorrect display of a low battery indicator even after the battery voltage returns to normal.

Data sourced from openFDA. This site is unofficial and independent of the FDA.